Hematologic Neoplasms
Conditions
Keywords
Hematologic Neoplasms, Supportive Therapy, Fatigue, Mind-body medicine, Complementary and alternative medicine
Brief summary
This randomized controlled trial aims to investigate the effectiveness of a mind-body group program as a supprtivemanagement strategy for fatigue in patients with malignant hematological diseases.
Interventions
BEHAVIORALMind-body medicine group program
The group program is mainly based on MBSR. It further integrates elements of the mind-body medicine cancer program of the Benson-Henry Mind/Body Medical Institute at Harvard Medical School which is rooted in psychoneuroendocrinology and focuses on relaxation techniques, exercise, cognitive restructuring, diet, and social support. In addition, naturopathic methods of selfregulation and self-care are incorporated.
Sponsors
Universität Duisburg-Essen
Robert Bosch Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with malignant hematological diseases in complete remission after primary chemotherapy and/or radiation * Physical and mental ability to attent 8 of 11 group units
Exclusion criteria
* Chemotherapy, radiation, or rehabilitation programm during the study period * Pregnancy * Participation in other studies with behavioral interventions during the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| General Fatigue | week 12 | Multidimensional Fatigue Inventory (MFI) - General Fatigue Subscale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| General Fatigue | week 24 | Multidimensional Fatigue Inventory (MFI) - General Fatigue Subscale |
| Physical Fatigue | week 12 | Multidimensional Fatigue Inventory (MFI) - Physical Fatigue Subscale |
| Reduced Activity | week 12 | Multidimensional Fatigue Inventory (MFI) - Reduced Activity Subscale |
| Reduced Motivation | week 12 | Multidimensional Fatigue Inventory (MFI) - Reduced Motivation Subscale |
| Mental Fatigue | week 12 | Multidimensional Fatigue Inventory (MFI) - Mental Fatigue Subscale |
| Qaulity of life | week 12 | Functional Assessment of Cancer Therapy - General (FACT-G) |
| Depression | week 12 | Hospital Anxiety and Depression Scale - Depression subscale (HADS-D) |
| Anxiety | week 12 | Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) |
| Stress | week 12 | Perceived Stress Scale (PSS) |
| Sleep | week 12 | Pittsburgh Sleep Quality Index (PSQI) |
| Physical activity | week 12 | Motion sensor (activPAL3, Pal Technologies, Glasgow, Schottland) |
| Fatigability | week 12 | 30-Second Chair Stand Test |
| Adverse Events | week 12 | Number of patients with adverse events |
Countries
Germany
Contacts
CONTACTHolger Cramer, PhD
CONTACTHeidemarie Haller, PhD
STUDY_DIRECTORGustav Dobos, Prof. MD
Center for Integrative Medicine and Health, University Hospital Essen, University of Duisburg-Essen
Outcome results
None listed